A Phase I Study of Niraparib Administered Concurrently With Postoperative RT in Triple Negative Breast Cancer Patients

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT03945721
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    Niraparib is a type of drug called a "PARP inhibitor", which blocks DNA (the genetic material of cells) damage from being repaired or may prevent damage from occurring in the first place. In cancer treatment, inhibiting PARP may help kill cancer cells by not allowing the cancer cells to repair its DNA damage or prevent DNA damage from occurring.
  • Radiation Therapy — RADIATION
    radiation therapy

Study Details

This research study involves Niraparib as a possible treatment for triple negative breast cancer.

Key Dates

Start date
Jul 11, 2019
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Niraparib
    * Niraparib will be administered orally on a daily basis * Radiation Therapy will be administered concurrently with Niraparib

Primary Outcome Measure

Maximum Tolerated Dose [ Time Frame: 10 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer Institute/Brigham and Women's HospitalBostonMassachusetts02115-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-

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